1984～2014年治疗性生物药物发展历程及展望

发布时间：2019-03-15 14:36

【摘要】：为了全面系统了解1984-2014年全球生物药物的发展历程,掌握30年来生物药物的发展脉络、上市药物特点、研发管线布局等信息,该文以Drugs@FDA、中国食品药品监督管理总局数据库、Pub Med、Embase.com、Clinical Trail.Gov等数据库为数据来源,系统采集国内外上市和在研的生物药物信息。对已经上市和在研的生物药物从创新程度、药物适应症分布、药物化学特性、药物研发阶段等方面进行了深入分析。结果表明全球生物药物在1996年以后开始快速发展,2001~2005年是生物药物成果最为显著的阶段。肿瘤、免疫系统疾病、内分泌和代谢疾病、血液系统疾病、骨骼肌系统疾病是生物药物研究的重点领域,上市药物较多。目前抗体已经发展成为治疗性生物药物的主宰药物,在肿瘤、消化、免疫、呼吸、泌尿、骨骼肌疾病、疾病诊断等不同领域广泛应用。
[Abstract]:In order to comprehensively understand the development process of the global biological medicine in 1984-2014, the development of the biological medicine in the past 30 years, the characteristics of the drug market and the layout of the R & D pipeline, etc., are available in the Drugs@FDA, the database of China Food and Drug Administration, the pub Med, the Embase.com, The database of Clinical Trail. Gov is the data source, and the system collects the domestic and foreign listing and the biological drug information. An in-depth analysis has been made on the degree of innovation, the distribution of drug indications, the chemical characteristics of the drugs, the stage of drug development, and so on. The results showed that the global biological medicine began to develop rapidly after 1996, and 2001-2005 was the most significant stage of the biological drug product. Tumor, immune system diseases, endocrine and metabolic diseases, blood system diseases, skeletal muscle system diseases are the key areas of the research of biological drugs, and the listed drugs are more. The current antibody has been developed into a dominant drug for therapeutic biological medicine, and is widely used in various fields such as tumor, digestion, immunity, respiration, urinary system, skeletal muscle disease, disease diagnosis and the like.
【作者单位】：沈阳药科大学工商管理学院;中国医学科学院医学信息研究所信息服务部;中国医学科学院北京协和医学院药物研究所;中国药理学会;
【基金】：NSTL面向重大新药创制专项专业化信息服务(No 2013XM51)
【分类号】：R95

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